真实世界研究助理项目经理/RWE Associate Project Manager

2021-01-13

Position: RWE Associate Project Manager


Report to: RWE Sr. Project Manger


Location: Beijing


DUTIES & RESPONSIBILITIES 

1.       Working within a highly qualified team leader you will coordinate Partner and CRO to fulfil project and maintain project timeline.

2.       Establish and monitor project budgets and expenditure.

3.       Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation

4.       Ensure adherence to protocol and other guidelines and requirements relevents to the project.

5.       Managing interfaces with other groups and vendors to support supplies management, laboratories, quality control etc.

6.       Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested

7.       Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required

8.       Managing data manager generated queries efficiently and responsible for study cost effectiveness

9.       Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on projects

10.    Accompany visit and Quality control visit for site, on-site inspection support

11.    Oversight outsourced project CRO or CRA work

12.    Maintain good relationship with KOL and GCP officer.

 

KNOWLEDGE AND COMPETENCIES 

1.       3-4 years+ of monitoring experience in phase I~IV trials as a CRA, experience in RWS is preferred

2.       Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data

3.       Native Chinese level and conversational English at least

4.       Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner

5.       Ability to produce accurate work to tight deadlines within a pressurized environment




欢迎您将个人简历发送至:talent@visenpharma.com,期待您的加入!